经微弧氧化钛铌锆锡合金的生物安全性评价

The biological safety evaluation of new Ti-24Nb-4Zr-7.9Sn coated with microarc-oxidation film

目的:评价低弹性模量钛铌锆锡合金(TNZS)表面应用微弧氧化技术进行改性后的生物安全性。方法:参照ISO7405-1997(E)/GB16886-1997最新标准,对该材料分别进行细胞毒性试验、溶血试验、口腔黏膜刺激试验、短期全身毒性试验。结果:体内外生物学试验结果表明:细胞毒性试验显示TNZS合金经微弧氧化处理后无细胞毒性;溶血率小于5%,有良好的血液相容性;口腔黏膜刺激试验未见异常组织学反应;短期全身毒性试验显示无明显短期全身毒性。结论:钛铌锆锡合金经微弧氧化技术改性后,显示了良好的生物安全性。

Objective：To evaluate the biological safety of oxidation film on new Ti-24Nb-4Zr-7.9Sn by microarc oxidation. Method： According to the ISO7405-1997 （E） / GB 16886-1997, the samples were prepared and tested with the cytotoxicity test,in vitro hemolytic test,oral mucous membrane irritation test and acute general toxicity test. Result：The result of cytotoxicity test showed that the samples had no cytotoxicity. The result of in vitro hemolytic test showed that the hemolytic rates of all samples were lower than 5%. The result of oral mucous irritation test showed that all samples had no mucous membrane irritation. The result of acute general toxicity test showed that all samples had no acute general toxicity. Conclusion： The new microarc oxidized Ti-24Nb-4Zr-7.9Sn alloy possesses good biological safety.